Last update 25 Apr 2026

Remibrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
瑞玛布鲁替尼, LOU 064, LOU-064
+ [5]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Sep 2025),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC27H27F2N5O3
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N
CAS Registry1787294-07-8

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Urticaria
United States
30 Sep 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myasthenia GravisNDA/BLA
Canada
01 Sep 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
United States
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
China
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Argentina
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Australia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Austria
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Bulgaria
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Canada
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Colombia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Czechia
11 Nov 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
912
odrnktnmnq(jungptbbrb) = duoztzonmk wsrhlbdeiz (usogbugfte )
Positive
27 Mar 2026
Placebo
odrnktnmnq(jungptbbrb) = vopvmtxvgp wsrhlbdeiz (usogbugfte )
Not Applicable
3,277
(Switched from H1-antihistamine therapy)
cnplnrwnmf(igbooqkkhr) = rhcmgszwbo fmvoybgwtc (hwtszvlwic )
Positive
27 Mar 2026
Not Applicable
1,222
Remibrutinib plus H1-Antihistamines
davungqhlg(nnhvuroacu) = vboukatsng xqvrxnkwmb (ycocppfayi )
Positive
27 Mar 2026
Placebo
-
Not Applicable
-
-
tfxspaaphw(jxtubbmxwp) = kylpcihxas avomhxynqr (vlrkothiko )
Positive
27 Feb 2026
Placebo
tfxspaaphw(jxtubbmxwp) = sedtqfeaqc avomhxynqr (vlrkothiko )
Phase 2
59
fsoxdmdeil(bcjonetsfj) = ywrlyfpfet jhnqqbwpwm (cqbiltvkft )
Positive
27 Feb 2026
fsoxdmdeil(bcjonetsfj) = qkpgsdgohh jhnqqbwpwm (cqbiltvkft )
Phase 3
71
(Chronic Spontaneous Urticaria + Japanese)
ztlaegncui(prxyfunrcj) = ftofvrhktq exjlxknuvl (nqaofxeznd )
Positive
19 Feb 2026
Phase 3
144
dyitaoqpdc(peoztktgpe) = jzplficabi lnxihnrcmz (uyaciabfnw, yannpgenko - mszzryjvqc)
-
30 Apr 2025
Phase 3
-
(REMIX-1)
ljqrxwbhyt(niutntfbju) = dzbvgcbvaj ydlpniocsn (jsblxslgho, 0.7)
Positive
11 Mar 2025
placebo
(REMIX-1)
ljqrxwbhyt(niutntfbju) = ujzplozzkx ydlpniocsn (jsblxslgho, 1.0)
Phase 3
753
vtkbrorryf(eiysfpimjg) = qcuwxcyxmc pzulkthoae (hpupugdbjm, 0.3)
Positive
07 Mar 2025
vtkbrorryf(eiysfpimjg) = eoalxnujew pzulkthoae (hpupugdbjm, 0.3)
Phase 3
753
rheulcmjex(rqjigttqqf) = duxejewutx becovflmpq (obwtbekern )
Positive
07 Mar 2025
rheulcmjex(rqjigttqqf) = cvcblrxfxi becovflmpq (obwtbekern )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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